Radius Health NDA Approved for Osteoporosis

FDA has approved a Radius Health NDA for Tymlos (abaloparatide) injection for treating postmenopausal women with osteoporosis at high risk for fracture. In such women, Tymlos reduces the risk of vertebral and nonvertebral fractures. Approval was based on data from an 18-month trial called ACTIVE and the first six months of the ACTIVExtend trial that “demonstrated consistent significant and rapid reductions in the risk of vertebral and nonvertebral fractures regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral) and bone mineral density (BMD) at baseline,” the company says. “In addition, the anabolic effect of Tymlos was demonstrated in animal studies by increases in [bone mineral density] and bone mineral content that correlated with increases in bone strength at vertebral and/or nonvertebral sites.”